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Trial record 13 of 26546 for:    Change | Recruiting, Not yet recruiting, Available Studies

Diagnostic Value of Linked Color Imaging for Minimal Change Esophagitis in Nonerosive Reflux Esophagitis and GERD

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ClinicalTrials.gov Identifier: NCT03068572
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary:
Linked color imaging(LCI),a new system for endoscopy modality,creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of magnifying blue laser imaging(BLI) technology.LCI makes red areas appear redder and white areas appear whiter.Thus,it is easier to recognize a slight difference in color of the mucosa.This is a study to assess the effectiveness of LCI for diagnosing esophageal minimal endoscopic lesions and Los Angeles classification system when compared to conventional white-light endoscopy (WLI).Gastroesophageal reflux disease(GERD) is a common disease that be defined as a condition which develops when the reflux of stomach contents cause troublesome symptoms and/or complications.Esophageal injury was classified according to the Los Angeles classification system,Non-erosive reflux disease(NERD) is defined by the presence of troublesome reflux-associated symptoms and the absence of mucosal breaks at endoscopy,which includes minimal change oesophagitis and no endoscopic abnormalities.LCI improved the visualization of the squamocolumnar junction (SCJ) by enhancing the contrast,mucosa minimal changes could be seen more easily and clearly with LCI than with standard white-light endoscopy.By comparing White-light endoscopy and LCI,it will show if there is any comparable advantage to using one or the other for lesion detection.

Condition or disease
Gastroesophageal Reflux Disease Minimal Change Disease Non-Reflux Esophagitis

Detailed Description:
This is a prospective study comparing the use of linked color imaging(LCI) versus standard white light for the detection of minimal change esophageal.Gastroesophageal reflux disease(GERD) is a common disease that be defined as a condition which develops when the reflux of stomach contents cause troublesome symptoms and/or complications.At present,more than half the patients with GERD symptoms were diagnosed as having nonerosive reflux disease(NERD).However,by careful analysis,the majority of NERD patients did not have completely normal endoscopic finding but were found to have subtle distal esophageal mucosal changes.Forty-eight patients with suspected minimal change esophageal reflux disease(positive GerdQ but normal conventional endoscopy)and forty asymptomatic control were recruited.The new LCI(GF-L590WR) was performed.The criteria for positive liquid crystal thermography (LCT) were:a)triangular indentation,b)punctuate erythema.

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Study on the Diagnosis of Minimal Change Esophagitis in Nonerosive Reflux Esophagitis and Gastroesophageal Reflux Disease Using Linked Color Imaging
Actual Study Start Date : January 15, 2017
Estimated Primary Completion Date : October 30, 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
NERD group
45 GERD patients without obviously abnormality were examined by conventional white-light endoscopy and then followed by Linked Color imaging(LCI) to evaluate minimal change esophagitis and observation agreement of Los Angeles classification system GERD patients with the absence of mucosal breaks at conventional endoscopy,and those patients was given standard or double dose of oral proton pump inhibitor (PPI) for 2 weeks to determine the efficacy of anti-secretory therapy (the so-called PPI test).The response to PPI treatment comprised the NERD group.
Control group
45 control patients were examined by white-light endoscopy and then followed by Linked Color imaging(LCI) to evaluate minimal change esophagitis and observation agreement of Los Angeles classification system,those subjects who had undergone endoscopy solely for the purpose of a health check-up at the same time of the study period



Primary Outcome Measures :
  1. observation minimal change esophagitis [ Time Frame: 5 months ]
    conducted to assess the effectiveness of LCI for diagnosing esophageal MCE when compared to conventional white-light endoscopy (WLI).Meanwhile, interobserver and intraobserver variation in the use of LCI system between endoscopists with different levels of experience.


Secondary Outcome Measures :
  1. Improvement observation agreement of Los Angeles classification system for GERD using LCI by comparing with that under white endoscopy [ Time Frame: 5 months ]
    It is anticipated that the use of Linked Color Imaging(LCI) will significantly improve the observation agreement of Los Angeles Classification when detected as opposed to White-light endoscopy



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Consecutive adult patients undergoing an outpatient endoscopy
Criteria

Inclusion Criteria:

  • age more than 18 year old
  • ability to provide written informed consent and undergoing an upper endoscopy
  • no PPI therapy in previous 2 weeks and no esophageal tumor or stenosis or history of esophageal surgery
  • Patients with more than 3 reflux episodes/week and absence of mucosal breaks at conventional endoscopy,The PPI test was positive

Exclusion Criteria:

  • unable to provide informed consent
  • erosive esophagitis or diagnosis of erosive esophagitis within the recent 6 months
  • presence of columnar lined epithelium
  • evidence of cancer or mass lesion in the esophagus, gastric lesions (ulcer, polyp, cancer)
  • previous gastrointestinal surgery
  • esophageal strictures
  • chronic use of medications known to affect esophageal motility
  • presence of systemic diseases that might interfere with esophageal motility
  • use of proton pump inhibitors(PPI) or histamine2-receptor antagonists in the last 4 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068572


Contacts
Contact: Pei Deng, Ph.M. +86-010-66947473 dengpei1983@21cn.com
Contact: Min Min, Ph.D. +86-010-66947473 minmin823@sina.com

Locations
China, Beijing
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences Recruiting
Beijing, Beijing, China, 100071
Contact: Yan Liu    +86-010-66947473    13911798288@163.com   
Principal Investigator: Min Min, M.D.         
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Investigators
Principal Investigator: Yan Liu, Ph.D. Affiliate Hospital to Academy of Military Medical Sciences

Publications of Results:
Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT03068572     History of Changes
Other Study ID Numbers: 307LCI-MCE
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences:
minimal change esophageal reflux disease diagnosis
Linked Color imaging
non-erosive reflux disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophagitis
Esophagitis, Peptic
Nephrosis, Lipoid
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Nephrosis
Kidney Diseases
Urologic Diseases